Fisma, Inc.
United StatesFDA applicant, unverified
- Devices
- 4
What Fisma, Inc. makes
Fisma, Inc. manufactures dental and medical laser systems, including models like the DENTAL 200, DENTAL 300, and DENTAL 400 for dental procedures, as well as the ATLAS-ELITE, CORIUM series, and ELITE variants for soft tissue treatments. The company also produces vein treatment lasers such as VEINLASE and SPECTRUM K8, alongside compatible peripherals like the PC LASER WITH SMART PLUG. These devices are designed for precision applications in dentistry, cosmetic surgery, and vascular treatments.
The company’s portfolio is classified under FDA Class II devices and is authorised through 510(k) clearances in the United States. These products are listed in the FDA’s 510(k) registry, reflecting their regulatory compliance for commercial distribution in the US market. Fisma, Inc. is headquartered in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Pc Laser With Smart Plug (Pc Edo & Dental 200) Ref K963124
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Fisma, Inc. have in the registry?
The registry currently lists 4 devices for Fisma, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Fisma, Inc.'s devices?
Among its 4 most recently registered devices, Fisma, Inc. has devices listed in FDA 510(k) (4 devices).
What risk classes do Fisma, Inc.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Fisma, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Fisma, Inc. in the registry?
The most recently registered devices listed for Fisma, Inc. include DENTAL 200, DENTAL 300, DENTAL 400, MODELS E-20, E-60, E-50, ATLAS-ELITE, MODEL E-80, CORIUM 200, CORIUM 400, MODEL E-90, ELITE, MODEL E-80-II, ELITE ULTRA, MODEL E-80-IV, PC LASER WITH SMART PLUG (PC EDO & DENTAL 200) and VEINLASE, MODEL E50-K8-B5, SPECTRUM K8, MODEL E50-K8-B9.